Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Invacare Corp. — Predicate Candidate Screening

111 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

73 daysmedian FDA review time

237 days90th percentile

111clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K071928	THE INVACARE FLYER, MODEL IPC 100	Invacare Corp.	2007-12-12	153	0
K070321	TWILIGHT FULL FACE MASK	Invacare Corp.	2007-04-30	87	0
K062402	EASYSTAND EVOLV	Invacare Corp.	2006-09-21	35	0
K061874	INVACARE'S TWILIGHT II NASAL MASKS	Invacare Corp.	2006-09-05	64	0
K033819	INVACARE 3G TARSYS	Invacare Corp.	2004-06-04	178	0
K031176	INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000	Invacare Corp.	2004-03-25	346	0
K031064	INVACARE POLARIS EX CPAP, MODEL ISP3000	Invacare Corp.	2004-03-12	344	0
K030814	INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 &	Invacare Corp.	2003-03-20	6	0
K022642	TWLIGHT, MODEL ISP 9600	Invacare Corp.	2003-02-11	187	0
K023589	STORM TDX POWER WHEELCHAIR	Invacare Corp.	2002-11-19	25	7
K021685	VENTURE HOMEFILL II WITH OXYGEN CONSERVER	Invacare Corp.	2002-07-23	62	0
K020386	INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02	Invacare Corp.	2002-07-02	146	2
K021680	INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91	Invacare Corp.	2002-06-18	27	6
K013516	INVACARE ELEVATING SEAT OPTION ESS6	Invacare Corp.	2001-12-13	51	0
K012909	XTERRA GT POWER WHEELCHAIR	Invacare Corp.	2001-10-24	55	0
K012927	M71 POWER WHEELCHAIR	Invacare Corp.	2001-09-19	19	0
K012370	SOLARA JR. MANUAL WHEELCHAIR	Invacare Corp.	2001-08-03	8	3
K012167	MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR	Invacare Corp.	2001-08-01	20	0
K003561	INVACARE PASSOVER HUMIDIFIER MODEL ISP9700	Invacare Corp.	2001-04-17	148	0
K010364	MCC-MIV ONE 2 ONE SOFTWARE	Invacare Corp.	2001-03-22	43	0
K003939	VENTURE HOME FILL II, MODEL IOH 200	Invacare Corp.	2001-03-21	90	1
K010135	MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3	Invacare Corp.	2001-02-16	30	1
K002284	VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX	Invacare Corp.	2000-10-24	90	0
K002317	MODEL 9000 BARIATRIC WHEELCHAIR	Invacare Corp.	2000-08-25	25	0
K002157	RANGER II M6, MODEL IN-888WNL	Invacare Corp.	2000-08-25	39	0
K002171	INVACARE LIFT CHAIR	Invacare Corp.	2000-08-10	22	0
K002170	MODEL 9000 PEDIATRIC WHEELCHAIR	Invacare Corp.	2000-08-04	16	0
K001777	MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS	Invacare Corp.	2000-07-24	41	1
K000174	ACTION AF-1 WHEELCHAIR	Invacare Corp.	2000-02-18	29	0
K993413	STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCO	Invacare Corp.	1999-12-15	64	2
K992643	MODEL IRC 1001 AEROSOL COMPRESSOR	Invacare Corp.	1999-10-27	82	0
K983627	VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM	Invacare Corp.	1999-10-22	372	0
K991119	TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G	Invacare Corp.	1999-08-19	139	1
K992052	MODELS LYNX AND PANTHER MOTORIZED SCOOTERS	Invacare Corp.	1999-08-12	55	0
K984295	INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)	Invacare Corp.	1999-07-09	220	0
K991168	ARROW FWD POWER WHEELCHAIR	Invacare Corp.	1999-06-25	79	2
K990157	MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR	Invacare Corp.	1999-02-03	15	0
K982242	INVACARE CPAP	Invacare Corp.	1999-01-27	216	0
K984447	MODEL ACTION AT II MANUAL WHEELCHAIR	Invacare Corp.	1999-01-08	25	1
K983777	MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM	Invacare Corp.	1998-12-18	53	0
K982064	ACTION STORM RANGER II, ACTION STORM POWER 9000	Invacare Corp.	1998-10-05	115	0
K982336	KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS	Invacare Corp.	1998-08-21	46	2
K974296	MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC B	Invacare Corp.	1998-01-06	50	0
K973468	MODEL IRC 1199 SCOUT NEBULIZER	Invacare Corp.	1997-12-08	87	0
K960411	MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOT	Invacare Corp.	1996-03-18	49	0
K953852	MODEL IPD OXYGEN CONSERVING DEVICE	Invacare Corp.	1995-11-22	98	0
K950724	MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHA	Invacare Corp.	1995-08-07	172	0
K950681	MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LO	Invacare Corp.	1995-05-16	91	0
K951138	MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS	Invacare Corp.	1995-03-20	7	0
K940972	MODEL MCC - MKIV MICRO COMPUTER CONTROLS	Invacare Corp.	1994-06-02	91	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda